The Commonwealth of Massachusetts

Executive Office of Health and Human Services Department of Public Health 250 Washington Street, Boston, MA 02108-4619
DEVAL L. PATRICK
GOVERNOR

TIMOTHY P. MURRAY
LIEUTENANT GOVERNOR

Tel: 617-624-5000 Fax: 617-624-5234 www.mass.gov/dph

JOHN W. POLANOWICZ
SECRETARY

LAUREN A. SMITH, MD, MPH

INTERIM COMMISSIONER

TO: FROM: DATE: RE:

Interim Commissioner Lauren Smith and Members of the Public Health Council DPH Medical Marijuana Work Group1 May 8, 2013 Request for Approval for Promulgation of Regulations at 105 CMR 725.000: Implementation of An Act for Humanitarian Medical Use of Marijuana (Chapter 369 of the Acts of 2012)

______________________________________________________________________
INTRODUCTION The purpose of this memorandum is to request approval for promulgation of 105 CMR 725.000, Implementation of An Act for Humanitarian Medical Use of Marijuana. The proposed regulation implements requirements enacted in Chapter 369 of the Acts of 2012. BACKGROUND On November 6, 2012, Ballot Question 3, An Initiative Petition for a Law for Humanitarian Medical Use of Marijuana passed with a 63.3% vote (and with a majority in 349 of 351 communities), making Massachusetts the 18th state in the nation in addition to the District of Columbia to approve the use of marijuana for medical purposes. This measure, now Chapter 369 of the Acts of 2012 (the Act), became law on January 1, 2013 and allows qualifying patients with certain defined medical conditions or debilitating symptoms to obtain and use marijuana for medicinal use. Additionally, the law requires the Department of Public Health (Department or DPH) to issue regulations providing critical implementation and policy framework by May 2013. The Act eliminates state criminal and civil penalties for the medical use of marijuana by qualifying patients. In order to qualify, a patient must have been diagnosed with a debilitating medical condition as defined in the statute2 and have obtained a written certification from a physician with whom the patient has a bona fide physician-patient
1

DPH Medical Marijuana Work Group: Cheryl Bartlett, Alice Byrd, Dr. Madeleine Biondolillo, Julian Cyr, Dr. Alfred DeMaria, Andy Epstein, Priscilla Fox, Donna Levin, Alison Mehlman, Kara Murray, Jenny Nathans, Lydie Ultimo, Iyah Romm, Dr. Lauren Smith, and Jay Youmans. 2 ![C]ancer, glaucoma, AIDS or HIV, Hepatitis C, ALS, Crohns disease, Parkinsons disease, Multiple Sclerosis, and other conditions as determined in writing by a qualifying patients physician.

relationship. This certification must state the patients specific debilitating medical condition and symptoms, as well as that the potential benefits of the medical use of marijuana outweighing any associated health risks for the patient. The law allows a patient to possess up to a 60-day supply of marijuana for his or her personal use, with DPH to define said quantity and the process through regulation.3 A patient may designate a personal caregiver to assist the patients use of medical marijuana; however, the designated caregiver must be at least 21 years old and have registered as a caregiver with DPH. The caregiver, under statute, is prohibited from consuming that supply of medical marijuana. A qualifying patient who has verified financial hardship, a physical inability to access reasonable transportation, or the lack of a treatment center within a reasonable distance of the patients residence may obtain a hardship cultivation registration from DPH. This allows the patient or caregiver to cultivate only enough plants in an enclosed, locked facility (as defined by regulations) to maintain a 60-day supply of marijuana for the patients personal use (known as home-cultivation or the hardship waiver). DPHs intent is to minimize home-cultivation through stringent caregiver provisions, incentivized compassion programs or low- or no-cost means tested programs at dispensaries, as well as allowing home delivery by treatment centers (i.e. courier system). The Act allows medical marijuana treatment centers (MMTCs) to cultivate, process and provide medical marijuana to patients or their caregivers. A treatment center must be a non-profit and apply for a DPH registration by complying with several mandates that include paying a fee, identifying a location with up to one additional location, and submitting operating procedures to DPH that include cultivation and storage of marijuana only in enclosed and locked facilities.4 A treatment centers personnel, known as dispensary agents, must be registered with DPH prior to working or volunteering at a center. Dispensary agents must be at least 21 years of age and have no prior felony drug convictions.5 In calendar year 2013, DPH may register up to 35 treatment centers statewide, with a minimum of one but no more than five centers per county. This number can be modified by DPH in later years. Fraudulent use of a registration card or cultivation registration is a crime punishable by up to six months in a house of correction. However, if the fraudulent use was for the sale, distribution or trafficking of marijuana for non-medical use for profit, it is a crime punishable by up to five years in state prison or by two and one-half years in a house of correction. The law does not: 1. Give immunity under federal law or obstruct federal enforcement of federal law; 2. Supersede Massachusetts laws prohibiting possession, cultivation, transport, distribution, or sale of marijuana for non-medical purposes; 3. Allow the operation of a motor vehicle, boat or aircraft while under the influence of marijuana;
3

DPH and key stakeholders interpret this definition of a 60-day supply to specifically refer to possession, not necessarily a patient-specific, clinically appropriate quantity. This 60-day supply may be overcome with evidence of a particular qualifying patients appropriate medical use. 4 Per the Act, DPH must set application fees so as to defray administrative and regulatory costs of the program and make the law revenue neutral. 5 Per the Act, a CORI check of these employees must be done.

4. Require any health insurer or government entity to reimburse any person for the expenses of the medical use of marijuana; 5. Require any health care professional to authorize the use of medical marijuana for a patient; 6. Require any accommodation of the medical use of marijuana in any workplace, school bus or grounds, youth center or correctional facility; and 7. Require any accommodation of smoking marijuana in any public place. Until the approval and issuance of final DPH regulations, and full implementation of the program, written certification by a physician will constitute a registration card for a qualifying patient. Similarly, until issuance of final regulations and full implementation of the program, a certified mail return receipt showing compliance with section 12 (A)(2)(b) of the Act by a qualifying patient, and a photocopy of the patients application, will constitute a registration card for that patients personal caregiver. Additionally, until DPH issues final regulations and the program is fully implemented, the written recommendation of a qualifying patients physician will constitute a limited cultivation registration; however, limited is not defined. Finally, until final regulations are published, the law allows the qualifying patient to cultivate his or her own supply of marijuana and does not tie this to DPH approval of the 60-day supply limitation. As a practical matter, many aspects of these interim provisions will have to remain in effect even after the final regulations are promulgated, due to the time needed to bring the licensed and approved MMTCs into operation. Chapter 369 clearly codifies that criminal penalties for non-medical uses of marijuana remain in place, with the law simply exempting persons in compliance with the law from penalties under state law. The law does not purport to give immunity for violations of federal law. Efforts have been made to project statewide need and demand. Although experiences in Colorado, among other states, demonstrate that high acuity conditions represent only a modest proportion of overall patient use, there were 37,049 invasive cancers of all types diagnosed among Massachusetts residents in 2008.6 As of December 2011, there are 18,170 individuals living with HIV or AIDS in Massachusetts. There are approximately 5,000 residents in the Commonwealth living with multiple sclerosis (MS), 600 with amyotrophic lateral sclerosis (ALS), and 100,000 with Hepatitis C. In Colorado, two percent of the total population is registered in Massachusetts that rate would yield 132,000 registrants.7 PUBLIC ENGAGEMENT AND COMMENTS PRIOR TO ISSUANCE OF DRAFT REGULATIONS On February 13, 14, and 27, 2013, the Department conducted listening sessions in Worcester, Boston, and Holyoke respectively. These sessions provided DPH the opportunity to engage a wide array of stakeholders and content experts prior to issuance of draft regulations, including legislators, patient-advocates, nationally-recognized dispensaries, prevention advocates, leading clinician and physician groups, municipal leadership, and law enforcement, all while actively learning from other states experiences. During these well-attended events (200+ attendees at each session), the public shared a range of ideas on how to shape the developing program. DPH has been actively soliciting input from these interested parties in shaping these regulations in an effort to put in place a system that is right for Massachusetts, ensuring both appropriate access, as well as safe and secure communities. It remains clear that
6 7

Massachusetts Community Health Information Profile (MassCHIP) Colorado Family Physicians' Attitudes Toward Medical Marijuana, Journal of the American Board of Family Medicine, 2013-01-01

Massachusetts success is contingent upon a tight regulatory scheme and industry and patients both agree. In addition to more than a total of 150 testimonials at the three listening sessions, DPH received 68 letters from individual stakeholders, as well as written comments from 16 organizations. Additionally, DPH staff met with more than 20 organizations individually, as well as engaged legislative leadership. DPH also received comment covering a wide range of topics, and ranging from high-level policy concerns to detailed comments about program development and individual registration. DPH heard recurrent themes regarding access, product quality, ensuring appropriate use among minors, 60-day supply, definition and dynamics of a physician-patient relationship, definitions and parameters of debilitating medical conditions, as well as municipal oversight concerns. The public also expressed concerns regarding security, advertising, home-cultivation and cost. Many suggested a single, centralized, tightly controlled cultivation facility with distribution statewide to maximize security and product quality. Many advocates and industry representatives have been generally opposed to a centralized cultivation model due to significant concerns that federal law enforcement agencies will specifically target a facility of the necessary size to provide broad supply. PUBLIC COMMENT ON DRAFT REGULATIONS On April 10, 2013, the Department presented these draft regulations to the Public Health Council, and received extensive comment on a variety of topics. That comment is summarized along with public testimony received, as appended. The Department then conducted three public hearings, in Northampton and Plymouth on April 19, 2013, and in Boston on April 22, 2013. These sessions provided DPH the opportunity to hear from a wide array of stakeholders and content experts who had extensive comment on the draft regulations, including patientadvocates, nationally-recognized dispensaries, prevention advocates, leading clinician and physician groups, municipal leadership, and law enforcement. More than 75 individuals testified in total at these hearings, and many more attended. Additionally, the Department received 197 written comments on these regulations. Each comment received, written and oral, was reviewed thoroughly by the DPH Medical Marijuana Work Group. Each was given equal consideration in the development of a final regulation. The following key policy recommendations reflect all significant, substantive changes to the draft regulation as presented on April 10, as well as those issues that the Department considered, but that did not result in revisions included in the final proposed regulation. Although not all specific comments are addressed in the responses below, all were considered. 1. Continuing Medical Education (CME): Initial Draft Regulation: DPH initially recommended that a physician must complete a minimum of 2.0 Category 1 continuing professional education credits (CMEs) on the subject of medical marijuana before certifying a debilitating medical condition and recommending the potential benefits for use of medical marijuana. To ensure access, DPH recommended that implementation of this requirement should be delayed for at least one year after promulgation of regulations. DPH envisions that these CME events may be online to allow greater access and ease of use by physicians. The session should include an explanation of the proper use of marijuana, including

contraindications, side effects, and dosage, and shall also include information on substance abuse recognition, diagnosis, and treatment related to marijuana. DPH will require that registering physicians attest to having completed a CME course prior to registration. Comment Received and Response: Many provided comment supporting the CME requirement. Many others provided comment that while well-intended, the CME requirement would have a chilling effect on physician participation and subsequently reduce access for patients. While DPH recognizes these concerns, physician education on this topic is paramount to a successful, high quality program, and recommends that no revision be made. DPH has pushed back the proposed start-date for this requirement from January 1, 2014 to July 1, 2014. DPH has also added a statement clarifying that contraindications with other psychotropic medications should be included in the education.

2. Debilitating Medical Condition Initial Draft Regulation: DPH initially recommended adopting the statutory language as is for debilitating medical condition with minor modifications (in bold)8 but further defining debilitating as follows: Debilitating means causing weakness, cachexia/wasting syndrome, intractable pain, or nausea, or impairing strength or ability, and progressing to such an extent that one or more major life activities are substantially limited. Patients who have had a diagnosis of a debilitating medical condition in the past but do not have active disease and are not undergoing treatment for such condition are not suffering from a debilitating medical condition for which the medical use of marijuana is authorized. Comment Received and Response: DPH received comment on the definition of debilitating medical condition, and on the corollary definition of debilitating. Comment was balanced, with many stating that these definitions are too restrictive, and others stating that they are not restrictive enough. DPH believes that as written, these definitions strike a careful balance of promoting appropriate access for patients with identified need, while mitigating inappropriate use and subsequent potential for diversion. Many indicated that DPH should add specific conditions to the list presented in statute, while others suggested DPH should eliminate the provision and other conditions as determined in writing! DPH cannot eliminate said provision as it is explicitly in the Act, and believes that adding conditions to the list presented is inappropriate and instead should be a determination made by a certifying physician on a case-by-case basis. DPH also received comment expressing concern that as defined, patients whose symptoms were alleviated by marijuana for medical use, would effectively cycle between periods of utilization. DPH amended certification provisions to clearly indicate that such patients would be allowed to continue maintainance use.

3. Defining a 60-Day Supply

8

Debilitating Medical Condition means cancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome (AIDS), hepatitis C, amyotrophic lateral sclerosis (ALS), Crohns disease, Parkinsons disease, and multiple sclerosis when such diseases are debilitating, and other debilitating conditions as determined in writing by a qualifying patients physician.

Initial Draft Regulation: DPH recommended allowing up to 10 ounces of finished product in leaf form (or equivalent) as a 60-day supply for the purposes of defining a maximum amount of medical marijuana that can legally be possessed at a given time. This amount of supply was based on a review and comparison of dispensing across states as well as stakeholder feedback. DPH proposed describing only a cap so that the certifying physician can use his or her best judgment in describing the needs of his/her individual patient. DPH further recommended that a physicians certification for a debilitating condition must indicate the time period for which such certification is valid; however, this physician determination may not exceed one year. The amount of medical marijuana that a patient may be dispensed would be in direct proportion to the period of time indicated in the certification; up to 10 ounces for a 60-day supply (e.g. certification for 15 days would allow dispensing of up to 2.5 ounces). Comment Received and Response: DPH received extensive comment on the 60-day supply, including many who testified that the supply was insufficient, and many others who indicated that 10 ounces is too much for this period of time. Many of the former indicated support for the provision allowing physicians to override the 10 ounce cap where extenuating circumstances indicate additional supply is necessary. Recognizing the balance struck by the initial proposed regulation between the perspectives of many stakeholders, and between the legitimate needs of patients and concerns for safety and security of our communities, DPH recommends no revision to this provision.

4. Defining a Bona-Fide Physician-Patient Relationship Initial Draft Regulation: Based upon the framework provided by BORiM, DPH recommended the following definition: Bona Fide Patient Relationship means a relationship between a physician, acting in the usual course of his or her professional practice, and a patient in which the physician has conducted a clinical visit, completed and documented a full assessment of the patients medical history and current medical condition, has explained the potential benefits and risks of marijuana use, and has a role in the ongoing care and treatment of the patient. Comment Received and Response: Comments indicated widespread support for the definition of bona-fide physician-patient relationship. Comment was provided by several professional associations and by patient advocates that mid-level practitioners should be allowed to diagnose patients with debilitating medical conditions and provide written certifications accordingly. DPH recognizes M.G.L. c. 112, s. 80I, and has added a stipulation that nothing in this reguation shall be construed to limit the scope of practice of nurse practitioners. Additionally, subsequent to a request by a professional association, DPH has adopted a prohibition on allowing physicians to certify immediate family members. The association recommended that DPH align this requirement with the prescribing guidelines and regulation of BORiM for Schedule II medications, in which such a prescription can only be written in an emergency situation. DPH does not contemplate such emergencies being applicable to marijuana and therefore has prohibited this practice entirely. Where renewal certifications may occur remotely, DPH believes that any urgent need for accessing marijuana for medical use will be accounted for by the current model. 5. Hardship Cultivation

Initial Draft Regulation: Those states that allow home cultivation permit patients to select this approach without additional administrative process. A patients ability to cultivate at home is not dependent on financial, physical, or geographic hardship in those states. Pursuant to the Act, Massachusetts would be the first state to develop such criteria. In order to avoid the diversion and security complications associated with widespread home cultivation, DPH intends to minimize hardship cultivation by optimizing access through a variety of approaches, including: 1) mandating the provision of lowincome subsidies at all MMTCs, 2) allowing secure home delivery where necessary, and 3) encouraging personal caregivers to pick up product in lieu of cultivation. DPH therefore previously recommended the following criteria and definitions: Physical incapacity to access reasonable transportation: An inability to use public transportation or drive oneself; and Does not have a personal caregiver with a reliable source of transportation; and Does not have a MMTC that will deliver medical marijuana to the patients or personal caregivers primary address. Verified financial hardship: A patient who submits satisfactory evidence of being a recipient of MassHealth, Supplemental Security Income, or the applicants income does not exceed 133% of the federal poverty line, adjusted for family size. Lack of treatment center within a reasonable distance of the qualifying patients residence: Lacks a treatment center within a reasonable distance from the qualifying patients residence; and Does not have a MMTC that will deliver medical marijuana to the patients or personal caregivers primary address.

Comment Received and Response: Extensive comment was received on various elements of hardship cultivation. o Many proposed that DPH should not limit home cultivation to cases of hardship and that each registered qualifying patient should accordingly be allowed to cultivate at-will. The statute clearly stipulates that home cultivation can only occur pursuant to a hardship cultivation registration granted by the Department, based upon the factors of geographic, financial, or physical hardship. o Another comment challenged the proposed requirement that only one personal caregiver be allowed to cultivate on behalf of his or her registered qualifying patient. DPH has clarified this requirement to stipulate that hardship cultivation may occur at only one location, either at the primary residence of the patient or of one of the allowable personal caregivers. This revision allows a second personal caregiver, if any, to participate in cultivation, facilitating ongoing support of patients during times such as vacation, work-related travel, etc. o Further comment questioned the requirement that cultivation only occur at the registered qualifying patients or personal caregivers primary place of residence. DPH recognizes the challenge posed to individuals with a hardship cultivation registration who rent property and are unable to use that place of primary residence to cultivate. However, recognizing the limitations on hardship cultivation in and of itself imposed by the Act, the availability of personal caregivers, delivery models offered by MMTCs, and the significant concerns for security presented by cultivation at alternate locations, we believe that the

provision should remain as written. The waiver provision in the regulation would allow for modification on a case-by-case basis should no other means of accessing marijuana be available to a given patient. o DPH received comment that Department staff should not have the right to enter the home of registered qualifying patients and their personal caregiver(s), if any. DPH believes that a request for and acceptance of a hardship cultivation registration constitutes permission for the Department to conduct such inspections, as is consistent with MMTCs or health care facilities. o DPH received comment from patients and patient advocates that the proposed definition of verified financial hardship, 133% of federal poverty level (FPL), adjusted for family size, was too low, presenting access barriers to low income patients. As Massachusetts Health Care Reform provides for partial health insurance subsidization for people with income of up to 300% of FPL, DPH has amended this provision and adopted the standard of 300% of FPL adjusted for family size. o DPH also received comment that a patients enrollment in Social Security Disability Insurance (SSDI) should be accepted as a demonstration of financial hardship. DPH agrees that many patients enrolled in SSDI may qualify for verifiable financial hardship under these regulations, however, SSDI is not a means-tested benefit. Therefore, in and of itself, SSDI is not an indication of financial hardship. Patients enrolled in SSDI may apply for consideration of a verifiable financial hardship, for which a variety of factors would be considered. o DPH received questions as to whether a registered qualifying patient with a hardship cultivation registration could purchase marijuana from a MMTC as well. As the demonstration of hardship for a cultivation registration explicitly includes factors that would preclude acquiring marijuana from an MMTC, DPH has included provisions stipulating that patients with hardship cultivation registrations may not purchase products, other than seeds, from MMTCs. ! o Further comment was received suggesting that hardship cultivation be banned entirely. The Act explicitly protects individual cultivation within the defined parameters of financial, physical, or geographic hardship and cannot be banned by the Department. ! o DPH received comment that municipal governments and law enforcement agencies should be notified of the location of any registered qualifying patient who receives a hardship cultivation registration, or their personal caregiver, if any. DPH intends for law enforcement to have easy, real-time access to appropriate information in the Departments interoperable database. However, the generation of such lists would pose privacy and security concerns and would not be appropriate. ! 6. Laboratory Testing Initial Draft Regulation: While a clear need has been articulated, because there are as yet no established, widely accepted, and available tests for medical marijuana, DPH recommended requiring a quality assurance and periodic testing plan in the application for approval as a treatment center, and DPH would use responses in evaluating applications. DPH further recommended specifying a requirement that the MMTC must test for contaminants as specified by the Department, including at least pests, mold, mildew, heavy metals and the presence of pesticides, while including provisions such that the Department may require additional testing without regulatory change.

Comment Received and Response: Many provided comment that while they commended DPH for establishing laboratory testing requirements, that there was significant lack of clarity as to who would provide testing services, and with regard to details of operational testing requirements. Additionally, DPH identified that in a model of third party testing, there was lack of clarity as to the rights of laboratories to possess marijuana DPH proposes requiring that staff of these laboratories become registered as dispensary agents. Revisions have also established a framework of standards and independent accreditation for laboratories providing testing, while allowing flexibility in the regulations for modification as this industry emerges.

7. Municipal Oversight and Non-Conflict with Other Law Initial Draft Regulation: Recognizing the highly varied interest in regulating medical marijuana at the local level, DPH developed an inclusive, but non-burdensome framework for engaging municipal government. Notably, no other states regulations describe a specific role for local health. DPH thus recommended the following: o DPH has responsibility for the medical marijuana program throughout the state, including registration of individuals and MMTCs, inspection of MMTCs, enforcement, etc. It should be noted that involvement, partnership, or in some cases, the possibility of potential leadership of these efforts will be determined through sub-regulatory guidance and on an individual basis. DPH would not mandate any local involvement. Local governments, including boards of health, would be authorized to pass local regulations that do not conflict with state law. Local reasonable health regulations pursuant to c. 111, s. 31

o o o

Comment Received and Response: Widespread support was indicated for the deferential references to municipal engagement, while not providing an overly burdensome framework within which municipalities would have undue responsibility. In response to concerns expressed by landlords and municipal governments, DPH has added a broad section clarifying that the Departments regulations do not affect the existing rights of landlords. Additionally, DPH has clarified that the rights and responsibilities of other regulatory agencies, employers, or law enforcement authorities are not limited by the regulations.

8. Patient Designation of MMTCs and MMTC Operating Structure Initial Draft Regulation: DPH recommended that when applying for or renewing a registration card, a qualifying patient must provide the name, address and telephone number of the MMTC from which the qualifying patient or his or her primary caregiver will purchase medical marijuana, unless the qualifying patient will be applying for a hardship cultivation registration. A qualifying patient shall designate only one MMTC. Limiting a patient to one MMTC would give MMTCs the ability to plan for and cultivate an appropriate number of marijuana plants for their patients needs. It was thought that this would have cut down on waste and diversion, while allowing for critical seed-to-sale tracking. A qualifying patient would then be able to change his or her designated MMTC

once in a 120-day period with notification to DPH. MMTCs would then limit their inventory of seeds, plants, and useable marijuana to reflect current patient needs as identified by the number of patients registered with the MMTC. Comment Received and Response: Nearly every individual and many entities providing testimony indicated that patients should not be required to designate an MMTC, and instead should be allowed to choose any MMTC at any time similar to a pharmacy model. DPH eliminated this requirement in the proposed final regulation. o DPHs concerns around product tracking and limiting excess cultivation and supply by MMTCs are largely mitigated by the requirement of comprehensive, electronic, seed-to-sale tracking including tracking across MMTCs. o Allowing patient choice will likely limit diversion and black-market sales as those sources would not be the secondary site of purchasing if the designated MMTC were not available. o Not all MMTCs will have the same products or strains. o This revision allows for the vagaries of life vacation, moving, etc. Similarly, most representatives of industry suggested that a model of solely vertical integration was too restrictive and would result in unintended consequences for patient care. Many commented that any individual or entity should be allowed to cultivate marijuana for the purposes of wholesale to MMTCs for dispensing. Others commented that MMTCs should not be required to cultivate, but should instead be allowed to operate only a dispensary, while purchasing marijuana from other sources. o DPH believes that a primarily vertical model is still optimal, to limit diversion, maximize control of product at every phase of development, and to ensure that MMTCs are engaged in every aspect of this business. o DPH recognizes concerns for protecting patient access during instances of crop loss or other unanticipated events. o DPH also recognizes that patients needs vary each MMTC may have different strains, different marijuana infused products (MIPs), or product in different forms - and as opposed to having to go from MMTC to MMTC, we see value in allowing a small proportion of stock to be shared between facilities. o DPH has added a provision allowing purchasing and sales of up to 30% of an MMTCs inventory in a given year, to be allowed only in emergency situations loss of crop, theft, or vandalism, etc. - or to meet a specific patients needs. o DPH believes that a vertically integrated model is the optimal model for the Commonwealth, as it is one that promotes appropriate access as well as maximizing community safety and security. As above, DPH has acknowledged that some inter-MMTC sales of product are necessary, but fully decoupling the cultivation and dispensing functions would be inappropriate. 9. Personal Caregivers Initial Draft Regulation: Personal caregiver was defined as a person who is at least twenty-one (21) years old who has agreed to assist with a qualifying patients medical use of marijuana, and is not the qualifying patients physician. An employee of a hospice provider, nursing, or medical facility providing care to a qualifying patient may serve as a personal caregiver. DPH recommended that except in the case of employee of a hospice, nursing facility, or medical facility providing care to a qualifying patient, a caregiver may only serve one patient. A qualifying patient may have up to two

10

caregivers. However, only one of the two personal caregivers may cultivate marijuana on behalf of the qualifying patient if said patient has obtained a hardship cultivation registration. Comment Received and Response: DPH received significant comment regarding the proposed model for personal caregivers. The proposed model limits personal caregivers to being able to care for only one patient except for specific circumstances such as family members or health care workers. A given patient may have up to two personal caregivers. o Comment was made that a personal caregiver should be allowed to care for more than one member of his or her family. This is consistent with our intent and DPH has clarified the provisions accordingly. o Extensive comment was made that personal caregivers are an integral component of a highly functioning medical marijuana system, and that limiting the number of patients a personal caregiver may serve as described above is overly restrictive, and inhibits a key sector of the industry. Similarly, these comments opposed the DPH model in which personal caregivers may not be compensated for their services. DPH believes firmly that allowing a model of caregivers as proposed in these comments is not consistent with the intent of the ballot initiative, which requires that an entity that cultivates, transfers, or dispenses medical marijuana is a MMTC. Notably, these comments were received primarily from individuals who seek to enter the market as personal caregivers. Though the caregiver limits will remain as initially proposed, DPH has, however, clarified that personal caregivers may be reimbursed for reasonable expenses incurred during the provision of services to their one allowed patient. o Comment was made that personal care attendants, home health aides, and visiting nurses should be included as health care workers for this provision, and DPH revised this regulation accordingly.

10. Youth Access Initial Draft Regulation: Recognizing the significant concerns of the pediatric community, DPH proposed a more restrictive model for access to those under 18 years of age. Notably, no other state prohibits youth access, despite the fact that the national American Academy of Pediatrics opposes the use of marijuana in children and youth. DPH proposed that for youth seeking medical marijuana, two physicians must certify the patients debilitating medical condition, at least one of whom must be a board-certified pediatrician. Additionally, parental consent should be required prior to youth registration. Finally, given concerns for long-term impacts of medical marijuana on normal neurological development, DPH proposed that youth access be restricted to only those youth with a life-limiting illness.9 Comment Received and Response: Multiple comments were received regarding restrictions on youth access, including life-limiting illnesses and requiring both parents rather than only one parent to approve use. o DPH has maintained the life-limiting provision, recognizing that there are

Life-Limiting Illness means a debilitating medical condition that does not respond to curative treatments, where reasonable estimates of prognosis suggest death may occur within six months.

11

significant concerns for harm to neurological development with marijuana use in youth. Recognizing the needs of certain patients, however, DPH has added an option by which the two physicians may override that provision as they deem appropriate taking into account the risks and benefits - there would then be additional documentation requirements to DPH. Recognizing comment from the PHC and others, DPH has also amended the definition of life-limiting to align with palliative care changing six months to two years. Consistent with requirements for general medical care and experimental therapies, DPH has maintained the requirement that approval of one parent or guardian is sufficient for use of marijuana. In instances in which there is a conflict between parents or guardians, DPH anticipates that physicians would make prudent decisions as in the case of any other therapy.

11. Miscellaneous Comments Pertaining to Patients and Physicians Comment Received and Response: DPH received extensive comment that all transitions periods before and after adoption of 105 CMR 725.000 should be clarified, such that patients, caregivers, and physicians understand the necessary steps to continue in their roles under the Act as the medical marijuana program is implemented. DPH provided such clarification throughout the regulation. Comment Received and Response: DPH received comment that the requirement for patients to register with DPH every five years was both unclear and too long a period of time. To eliminate confusion and coordinate the workflow of this process with all other registrations (hardship cultivation, MMTC, dispensary agent, etc.), DPH has amended the patient registration requirement to be annual. Comment Received and Response: A professional association commented that information about physicians who register with DPH and who issue written certifications should be confidential. Additionally, comment was received that should such information be made available publicly, it would chill physicians willingness to issue written certifications. Others expressed concern that the requirement that physicians report a patient's symptoms and debilitating condition violates HIPAA and M.G.L. c. 111, s. 70E. o DPH shares the concern that public dissemination of physician information may limit physicians willingness to issue written certifications. However, no statutory provision exists to protect this information from release under Massachusetts public records law. Information that identifies an individual patient, caregiver, or dispensary agent, will be protected in accordance with the Act. o Neither HIPAA nor M.G.L. c. 111, s. 70E prohibit health care providers from submitting confidential patient information to the Department when required.

12. Miscellaneous Comments Pertaining to MMTCs Comment Received and Response Escrow: Significant comment was received on the escrow requirement in Phase 1 of the MMTC application process. DPH has revised the process for documentation of financial viability to be solely a demonstration of liquid capital available still $500,000 instead of requiring an escrow account. An escrow account would not meet the intent of the provision, as it by definition could not be used

12

for operational expenses. DPHs intent is for MMTCs to demonstrate and have usable adequate start-up capital, as reflected in the revisions. Some comment was received that the $500,000 figure is too high, and that it would hinder the ability of local residents to engage in this industry. Notably, Connecticut has a capital requirement of $2M. Other states have similar requirements. Deliberation with many stakeholders suggests that year 1 costs to implement a medical marijuana program will likely be in the range of more than $1M. Reducing this figure seems inappropriate as DPH needs a mechanism to assess the ability of applicants to successfully operate a MMTC. Notably, however, DPH included a revision that if an entity is submitting more than one application, the capital requirement shall be $400,000 for each subsequent application. Comment Received and Response Liability Coverage: PHC members and public testimony suggested the need for liability coverage of MMTCs. DPH accordingly has added a provision requiring general and product liability coverage. DPH contacted insurers in other states and determined that access to coverage should not be a barrier. DPH would be the first state to have an explicit requirement for coverage of MMTCs. Coverage levels were determined in consultation with insurers. DPH has defined an escrow requirement as a secondary mechanism, to be paid out for general or product liability should coverage not be able to be obtained. Comment Received and Response Confidentiality of Certain Aspects of MMTC Applications and Sensitive Materials: Subsequent to comments about increasing safety and security, and limiting diversion, revisions have been made such that it is very clear that floor and security plans for MMTCs are intended to be exempt from Massachusetts public records law. Further, in response to legitimate concerns by prospective MMTCs that trade secrets or intellectual property would be entered into the public record through the application process, DPH has amended those requirements to allow abbreviated summaries of key documents. Comment Received and Response MMTC Products: Though clearly intended in the previous draft regulation, subsequent to comments received, DPH has added language expressly prohibiting adulteration of marijuana for medical use with psychoactive additives or other illicit substances. Additionally, in keeping with a legislative proposal in the Massachusetts House of Representatives, DPH has adopted language prohibiting the deceptive labeling of marijuana infused products to look like commercially available candy. Further, some comments expressed concern that by not defining edible MIPs as food, they would not be subject to appropriate sanitary regulation. Defining edible MIPs as food would require local boards of health to issue a food establishment permit to every MMTC that sells these products. The Department believes that this would place undue burden on local authorities. Instead, DPH has put into the regulations, a requirement that edible MIPs be produced in accordance with established food sanitation regulations and that all food handlers comply with sanitary requirements. Municipalities and local boards of health maintain the authority to further regulate MMTCs pursuant to 105 CMR 725.600. Comment Received and Response MMTC Application Processes: DPHs proposed regulation stipulated that MMTCs must be operational within 120 days of registration by the Department. In response to extensive comment that 120 days is impractical, DPH amended the previous requirement, instead allowing MMTCs to define a unique operational timeline in the application process. This timeline would then be

13

used to score applications. Further it is stipulated that MMTCs be held to that timeline. Additionally, many commented that the process was too heavily reliant on securing property, engaging municipal governments, and meeting local requirements. Many others, however, commented that local input is critical in the application process, and that without local support applicants were unlikely to successfully operate a MMTC, even if issued a registration by the Department. Accordingly: o DPH has amended the application process to maintain the emphasis on local engagement, such as seeking local support, securing siting, etc. However, DPH also has allowed applicants with less certainty about local process, such as siting, to apply. DPH allows applicants to indicate only a county of preference, however there is explicit recognition that the more specificity provided, the greater the likelihood of a successful application. o Recognizing the desire to have strong applicants enter the marketplace, DPH has also proposed a provision that would allow applicants to indicate a willingness to consider alteration of their proposed location (e.g. a strong applicant in County A who was not offered a registration, could have an opportunity to be considered for a MMTC registration in County B). o DPH has added a requirement that MMTCs notify local government upon being invited to submit a Phase 2 application. o Recognizing the need for continued oversight of siting, conformance with local requirements, and building of physical infrastructure, among other requirements, the Department has added provisions allowing for appropriate conditions to be placed upon an awarded MMTC registration, and requiring that the Department issue final approval prior to a MMTC initiating operations. Comment Received and Response MMTC Registration Renewal: Comment was received that given the significant investment in MMTC start-up, that registrations should be valid for longer than one year. The primary concern stated was that raising sufficient capital to start a MMTC would be challenging if an ongoing ability to operate is not assured. It is not DPHs intent that after each annual registration cycle, MMTCs would enter a competitive renewal process. Instead, in the absence of cause or other grounds for denial of renewal as established in the regulation, the registration of a MMTC would be renewed upon DPHs receipt of the appropriate renewal fee and requisite materials. This model is in keeping with license renewal requirements for health care facilities. DPH has modified the pertinent regulatory language to clarify this intent. Comment Received and Response Non-Profit Organizations: DPH received extensive questions regarding the references to and requirements of non-profit organizations, including questions about who may invest in or have ownership interest in such an entity. o DPH has clarified language around non-profit corporations, including adding specificity that all members of a non-profit including other companies, if any are to be held accountable for ensuring that the MMTC must act in furtherance of its non-profit purpose. Comment Received and Response Advertising: DPH received comment that requirements limiting advertising should be more stringent. The Department believes that the requirements as written, with minor clarifying language provided, are as stringent as is possible, consistent with the First Amendment of the United States Constitution and Article 16 of the Massachusetts Constitution.

14

Comment Received and Response Massachusetts Residency Requirements for Operating MMTCs: DPH received comment that MMTCs should have at least one, if not more, Massachusetts residents in leadership positions. DPH maintains that the most appropriate mechanism to encourage local engagement in this industry is to preferentially consider applications from Massachusetts residents (as well as women, minorities, and veterans). Comment Received and Response MMTC Operations: In response to concerns that commercial incinerators are not widely available in the Commonwealth, and in keeping with the Departments efforts to maximize environmentally friendly approaches, with guidance from the Massachusetts Department of Environmental Protection, DPH has redrafted the waste disposal sections of the regulation. New provisions allow for such disposal methods as composting, while ensuring that appropriate disposal will be possible for all MMTCs to mitigate any potential for diversion. DPH also received extensive comment on a variety of issues regarding employees of MMTCs and possession of or access to marijuana by those workers that may have reason to come into contact with it. DPH also received comment about minimum standards and training for dispensary agents. o In order to provide clarity, to allow for diverse staffing and contractual arrangements by MMTCs, and to protect the ability of employees of third-party laboratories providing testing services to possess marijuana within the parameters of their role, DPH has added language requiring that the responsible MMTC register each of these individuals as dispensary agents. DPH anticipates allowing for reduced-fee, short-term registrations to allow for potential consultants or similar. DPH also allows for a dispensary agent to be employed by multiple MMTCs, provided however that he or she is registered as a dispensary agent by each MMTC. o In order to ensure minimum competency, DPH has specified that all dispensary agents must receive at least 8 hours of on-going training annually.

SUMMARY OF OPERATIONAL NEEDS The Department is also in the process of identifying the programs operational needs, including analyzing necessary technology infrastructure. DPH anticipates the development of an online system for functions such as registration, fee collection, and auditing of patient eligibility. Developing and executing a rigorous and appropriately transparent procurement process, hiring staff, training inspectors, obtaining bridge funds, and implementing a plan for security and diversion prevention remain critical pre-roll out tasks that are intrinsically linked to the final production and enactment of the states regulations. As DPH moves forward from final promulgation of regulations, it is critical that a timeline for developing the infrastructure to support access to medical marijuana is available to stakeholders so that expectations for registration of patients, caregivers, and MMTCs are clearly established. Due to a lack of start-up resources provided by the ballot measure, the medical marijuana program is currently being developed with the existing expertise of an internal DPH team, including the DPH Medical Marijuana Work Group. Longitudinally, the program will be maintained through fees on participants once qualifying patients, providers, and treatment centers are registered. PROCEDURAL NEXT STEPS

15

This regulation will be filed with the Secretary of the Commonwealth on May 10, 2013, and will be published and effective on May 24, 2013. In the coming weeks, the Department will be issuing guidance pertinent for each category of registrant. This guidance will clarify application processes and timelines, as well as requirements in the period prior to full implementation of the medical marijuana program. In the coming weeks, the Department will conduct a hearing on the promulgation of fees to generate revenue necessary to support the medical marijuana program, as required by the Act. On an ongoing basis, as questions or concerns arise, the Department will maintain and update Frequently Asked Questions (FAQs) on its website, www.mass.gov/medicalmarijuana. This site will serve as the primary resource for patients, caregivers, physicians, and prospective MMTCs as this program is fully established.

16